Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Recruiting now · Phase 1/Phase 2

Conditions studied: HAM/TSP

In brief

Background: HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a rare, progressive disease. It occurs in some people infected with the HTLV-1 virus. It leads to weakness in the lower limbs and other serious problems. It has no treatment. Teriflunomide is a drug used to treat multiple sclerosis. It reduces immune cells that make the disease worse. Researchers want to learn if this drug can help people with HAM/TSP. Objective: To learn the effects, immune response, safety, and tolerability of teriflunomide in people with HAM/TSP. Eligibility: Adults ages 18 and older with HAM/TSP. Design: Participants will be screened under protocol 98-N-0047. Participants will have a medical history. They will have physical and neurological exams. They will have blood and urine tests. Participants will take 1 tablet of the study drug once a day for 9 months. They will keep a drug diary. Participants will have lymphapheresis. For this, blood is drawn from a needle in one arm. A machine divides the blood into red cells, plasma, and white cells. The white cells are removed. The plasma and red cells are returned to the participant through a needle in the other arm. Participants will have lumbar punctures ( spinal taps ). For this, a thin needle is inserted into the spinal canal in the lower back. Spinal fluid is removed. Participants will have magnetic resonance imaging (MRI) of the brain and spine. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, participants will lie on a table that can slide in and out of the scanner. Participation will last for 15 months.

Key facts

Study ID

NCT04799288

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

24

Starts

2021-09-24

Expected to finish

2029-12-31

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Alternative diagnoses that can explain neurological disability
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with participation for the full duration of the trial; or not in the best interest of the subject to participate, in the opinion of the treating investigator
• Severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections.
• Liver dysfunction, as indicated by baseline aspartate aminotransferase (AST) or alanine or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal
• Positive serological evidence of HIV, HTLV-II, Hepatitis B or C
• Treatment with immunomodulatory/immunosuppressive therapy is exclusionary except in the cases below:
• current use of topical steroids
• Study participants who have been prescribed <= 10 mg prednisone (PO) per day will be required to discontinue this medication for a period of at least 3 months (90 days) prior to enrolling in 21-N-0016. Additionally, participants who have been prescribed burst therapy with an oral steroid as an outpatient over the course of <= 10 days (e.g., Medrol Dosepak [methylprednisolone]), can enroll after discontinuing burst dose oral steroids for at least 3 months.
• Pregnant or lactating women.
• Treatment with other investigational drugs within 6 months before enrollment
• Known hypersensitivity to teriflunomide or leflunomide
• Concomitant treatment with leflunomide

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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